SHR2554 Plus Liposomal Mitoxantrone as First-line Treatment for Peripheral T-cell Lymphoma (PTCL)

NCT07725705 | Not Yet Recruiting Phase 1

• 1 other identifier: IIT2026083
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-arm, multicenter, Phase Ib/IIa study designed to explore the efficacy and safety of SHR2554 in combination with liposomal mitoxantrone for the treatment of patients with treatment-naive peripheral T-cell lymphoma (PTCL). The study is divided into a Phase Ib safety lead-in phase and a Phase IIa dose expansion phase.

Conditions

PTCL; First Line Treatment

Keywords

EZH2 inhibitor; SHR2554; Liposomal Mitoxantrone; First-line Treatment of PTCL; Zeprumetostat

Outcome Measures

Primary Outcomes (2)

• Incidence of Dose-Limiting Toxicities (DLT)

  Adverse events (AE) defined as DLT events per protocol

  Cycle 1 (28 days)

• Complete response (CR) rate

  The proportion of subjects evaluated as complete response (CR) according to Lugano 2014 efficacy evaluation criteria

  up to 6 months after enrollment

Secondary Outcomes (6)

• Objective response rate (ORR)

  up to 6 months after enrollment

• Duration of Response (DOR)

  up to 2.5 years post first treatment

• Duration of complete response (CR)

  up to 2.5 years post first treatment

• Progression-free Survival (PFS)

  Up to 2.5 years

• Overall survival (OS)

  Up to 2.5 years

Study Arms (1)

SHR2554 combined with Liposomal Mitoxantrone

EXPERIMENTAL

Drug: SHR2554 combined with Liposomal Mitoxantrone

Interventions

SHR2554 combined with Liposomal Mitoxantrone DRUG

Patients will receive 6 cycles of SHR2554 combined with liposomal mitoxantrone as induction therapy. All patients who achieve a complete response (CR) after induction therapy are eligible for transplantation. Patients achieving CR or partial response (PR), as well as those post-transplantation, may receive SHR2554 maintenance therapy in 28-day cycles. Maintenance therapy will continue until disease progression or other reasons for discontinuation. The maximum duration of SHR2554 administration in the maintenance phase will not exceed 24 months.

SHR2554 combined with Liposomal Mitoxantrone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old,regardless of gender;
• No prior anti-tumor therapy.
• There must be at least one measurable or evaluable lesion that meets the Lugano 2014 criteria for lymphoma: Measurable lesion: Nodal lesions with major diameter greater than 1.5cm and minor diameter greater than 1.0cm as assessed by PET/CT or Computed Tomography (CT) and/or Magnetic Resonance Imaging (MRI); Or the length of extranodal lesions \>1.0cm; 2)Evaluable lesions: PET-CT showed increased uptake in lymph nodes or extranodal regions (higher than liver) and imaging features consistent with lymphoma;
• ECOG performance status score: 0-2;
• Expected survival time ≥3 months;
• Have adequate organ and bone marrow functiont;
• No concurrent hemophagocytic lymphohistiocytosis (HLH). If a patient has clinically diagnosed HLH, enrollment eligibility will be determined by the investigator based on an evaluation of the patient's general physical condition following targeted anti-HLH therapy.
• Women of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose of medication; Effective contraception should be used from the time of informed consent until 6 months after the last dose of study drug.
• Capable of understanding the study procedures and voluntarily signing a written informed consent form (ICF).;

You may not qualify if:

• Prior treatment with epigenetic agents before enrollment;
• Patients with a history of severe cardiac disease, history of radiation therapy to the mediastinal/pericardial region, cumulative anthracycline dose \> 550 mg (doxorubicin equivalent), prior use of mitoxantrone, baseline left ventricular ejection fraction (LVEF) \< 50%, or history of exposure to other cardiotoxic drugs;
• History of other primary aggressive malignancies that are not in remission, or have been in remission for less than 3 years;
• Primary central nervous system (CNS) lymphoma or secondary CNS involvement.
• Known allergy or hypersensitivity to the study drugs or their related metabolites;
• Currently participating in another clinical study, or less than 4 weeks elapsed from the end of treatment in a previous clinical study to the planned start of study treatment;
• Pregnant or lactating women;
• Active infections;
• Medical History and Concurrent Conditions;
• History of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS);
• Patients with mental disorders or those unable to provide informed consent
• Any other condition deemed by the investigator to be unsuitable for study enrollment;

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Central Study Contacts

Liang Huang

CONTACT

+86 022-23608126; huangliang@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): March 1, 2030
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share